Category Archives: CE marking

Corrosion | Salt Fog Testing: Like taking your product to the beach

Posted on August 26, 2025 by Keith Cooper

Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at the spa it expected – instead – it’s a nightmare at the beach. That is Corrosion/Salt Fog Testing.. This testing … Continue reading →

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Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”

Posted on August 22, 2025 by Keith Cooper

Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone of medical device compliance. If you’ve ever stared at a test plan wondering, “Do I really need to define this?”—this … Continue reading →

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Adapting to Evolving U.S.-China Regulatory Dynamics

Posted on August 4, 2025 by Keith Cooper

Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts. … Continue reading →

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REACH/RoHS and Continuing Compliance

Posted on July 18, 2025 by Keith Cooper

* Until August 15th, if you mention this blog post we will offer special pricing (20% off) your full REACH and RoHS evaluation with F2 Labs. * We evaluate your device and keep it on autopilot, painlessly. The RoHS Directive 2011/65/EU+(EU)2015/863 started … Continue reading →

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FDA Enforcement Flags Data Integrity Risks at Overseas Labs

Posted on June 6, 2025 by Keith Cooper

The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket … Continue reading →

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Cybersecurity and the new Radio Equipment Directive

Posted on May 28, 2025 by Keith Cooper

So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business. Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices Starting August 1, 2025, the EU is tightening the screws on anything … Continue reading →

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Hexavalent Chromium Faces EU Ban Under New Regulatory Shift

Posted on May 21, 2025 by Clare Wolffe

ECHA has proposed a new EU-wide restriction to protect the public from the effects of hexavalent chromium, Cr(Vi). ECHA assessed the risks and found that Cr(Vi) is the most potent workplace carcinogen. People living near industrial sites are also at … Continue reading →

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Unregulated Certificates Warning and The Implications Under EU Law

Posted on April 23, 2025 by Clare Wolffe

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates. The warning explains that voluntary certificates issued by certification bodies not designated as notified … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU | Tagged , , , , , , | Comments Off on Unregulated Certificates Warning and The Implications Under EU Law

Is Machinery in Scope of the RoHS Directive?

Posted on April 13, 2025 by Peter Jolles

“My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Product Testing, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on Is Machinery in Scope of the RoHS Directive?

Taming the EMC Beast: A Guide to Pre-Compliance Testing

Posted on April 7, 2025 by Keith Cooper

Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials … Continue reading →

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